(413 days)
Not Found
No
The summary describes a standard lithotripter with imaging capabilities (X-ray and Ultrasound) for targeting, but there is no mention of AI or ML being used for any function, such as image analysis, treatment planning, or shockwave delivery optimization. The performance studies focus on electrical safety, EMC, and software validation, not AI/ML performance metrics.
Yes
Explanation: The device is indicated for the fragmentation of kidney stones and renal pelvic stones and for upper ureteral stones, which are therapeutic interventions.
No
The device is a lithotripter, used to fragment kidney stones. While it uses imaging for positioning and monitoring, its primary function is therapeutic (breaking stones), not diagnostic (identifying or characterizing disease).
No
The device description clearly outlines multiple hardware components including a shockwave generator, operator interface (industrial PC with dual monitors), water circulation subsystem, and patient handling subsystem. It also mentions optional C-arm X-ray fluoroscopy and ultrasound imaging units. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fragmentation of kidney and ureteral stones using extracorporeal shock wave lithotripsy (ESWL). This is a therapeutic procedure performed on the patient's body.
- Device Description: The device description details a system that generates and focuses shock waves to break up stones within the body. It also mentions imaging modalities (X-ray and ultrasound) used for positioning and monitoring during the procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is a therapeutic medical device used for a physical intervention on the patient, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).
Product codes
LNS
Device Description
The Lite-Med LM-9300 Plus is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 Plus system consists of a shockwave generator, an operator interface (industrial PC with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, two more optional subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 Plus both X-ray and ultrasound are used for patient positioning and monitoring purposes.
Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, ultrasound
Anatomical Site
kidney, renal calyx, renal pelvic, upper ureteral (stones)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Performance Data: The LM-9300 Plus is in accordance with the following safety and performance requirements, and provided in support of substantial equivalence:
- Electrical Safety and EMC
- O IEC60601-1
- IEC60601-1-2 O
- O IEC 60601-2-36
- O IEC61846
- O IEC62366
- ISO14971 O
- Software Verification and Validation Testing
- O IEC62304
- IEC/TR80002-1 O
Clinical Performance Data: Clinical performance is not required to demonstrate substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Storz Medical AG-Modulith SLK (K120769)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
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January 19, 2023
Lite-Med, Inc. Walt Hsu President & CEO 9th Floor, 49 Dongxing Road, Xinyi District Taipei. 11070 Taiwan
Re: K213772
Trade/Device Name: LM-9300 Plus Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: II Product Code: LNS Dated: December 16, 2022 Received: December 21, 2022
Dear Walt Hsu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213772
Device Name LM-9300 Plus
Indications for Use (Describe)
The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
510k Number: K213772
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
LITE-MED LM-9300 Plus Lithotripter
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the LM-9300 Plus is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices, which includes the following: Storz Medical AG-Modulith SLK (K120769).
SUBMITTER I.
Lite-Med Inc. 9th Floor, 49 Dongxing Road, Xinyi District Taipei City, Taiwan, Zipcode: 11070 Contact Person: Anderson Kuo Tel: +886-2-2218-0865 #207 Fax: +886-2-2218-2375 Email: anderson@lite-med.com Date Prepared: January 06, 2023
II. DEVICE
Proprietary Trade Name: LM-9300 Plus Common or Usual Name: Lithotripter, Extracorporeal Shock-Wave Classification Name: Extracorporeal Shock Wave Lithotripter Product Code: INS Regulatory Class: Class II with special controls Regulation Number: 21 CFR 876.5990 Panel: Gastroenterology/Urology
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III. PREDICATE DEVICE:
The Lite-Med LM-9300 Plus Lithotripter is substantially equivalent to the following currently marketed devices. For detailed information, please refer to section 12.
Storz Medical AG-Modulith SLK (K120769)
IV. Device Description
The Lite-Med LM-9300 Plus is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 Plus system consists of a shockwave generator, an operator interface (industrial PC with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, two more optional subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 Plus both X-ray and ultrasound are used for patient positioning and monitoring purposes.
Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
V. INDICATION FOR USE
The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Lite-Med LM-9300 Plus has the same technological characteristics as the predicate. The shock wave characteristics are measured by taking the guideline "Guidance for the Content of Premarket Notifications 510(k)s for Extracorporeal Shock Wave Lithotripters Indicated for the
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Fragmentation of Kidney and Ureteral Calculi" described in the consensus standard IEC 61846 "Ultrasonics – Pressure pulse lithotripters – Characteristics of fields" (1998) into consideration. Fiber Optic Probe Hydrophones are used in the measurements. The details of the measurements/calculations are given in relevant part of 510(k) application. The results are found similar to the predicate device characteristics.
Technical Elements:
-
- Shock wave generation type: Electromagnetic
-
- Shock wave used for fragment stone
-
- Use of a water cushion to deliver energy
-
- Treatment table used for moving patient position
-
- X-ray and Ultrasound used for localization
The following technological differences exist between the subject and predicate devices:
-
- Use of different x-ray system
-
- Use of different ultrasound scanner
VII. PERFORMANCE DATA
Non-Clinical Performance Data
The LM-9300 Plus is in accordance with the following safety and performance requirements, and provided in support of substantial equivalence:
- Electrical Safety and EMC
- O IEC60601-1
- IEC60601-1-2 O
- O IEC 60601-2-36
- O IEC61846
- O IEC62366
- ISO14971 O
- Software Verification and Validation Testing
- O IEC62304
- IEC/TR80002-1 O
Clinical Performance Data
Clinical performance is not required to demonstrate substantial equivalence to the predicate devices.
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VIII. CONCLUSIONS
From a clinical perspective and comparing design specifications, the LM-9300 Plus is substantially equivalent to the predicate devices. The LM-9300 Plus meets the FDA requirements stated in "Guidance for the Content of Premarket Notifications 510(k)s for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi" issued on Aug. 9, 2000. Lite-Med Inc. believes the minor differences of the LM-9300 Plus and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.